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QUALITY ENGINEER II

Katalyst Healthcares & Life Sciences

  • Holdrege, NE
  • 30+ days ago

    Highlights

    Provide critical quality engineering direction to Project Pearl with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans. Establishes a strong working relationship with all levels of operations to appropriately monitor and analyse in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects.

    Numbers & Facts

    LocationHoldrege, NE

    Description

    Responsibilities:
    • Support the plant on assigned product initiatives with technical expertise and determine associated resource needs to accomplish project goals.
    • Provide critical quality engineering direction to Project Pearl with respect to generally accepted quality engineering tools/principles, such as root cause analysis, FMEAs, risk mitigation, validation, DOE/other process improvement tools, measurement and measurement systems analysis, sampling, and control plans.
    • Applies moderate level application of technical principles, theories, concepts, techniques, and quality sciences / tools.
    • Develops solutions to routine problems of moderate scope.
    • Maintain alignment to company quality policies, procedures, and practices through consistent application of sound quality assurance principles. Make basic procedural updates.
    • Demonstrates working knowledge of applicable regulatory, Corporate and/or Unit requirements.
    • Is an extended team member representing Site Quality on product development projects and a team member for sustaining engineering projects.
    • Establishes a strong working relationship with all levels of operations to appropriately monitor and analyse in-process inspection, process control activity, waste and reject rates, PM compliance, environmental control, and customer complaint levels to take a lead role in identifying and documenting continuous improvement projects.
    • Approve protocols and reports for all validation and change control activities to ensure compliance to established procedures.
    • Utilize Lean and Six Sigma problem solving methods, data analysis tools and techniques to support department validation efforts around continuous improvement.

    Basic Requirements:
    • B.S. degree in Engineering (Industrial, Mechanic) or similar
    • 3+ Years Quality experience including Validation and Quality Engineering responsibilities.
    • Demonstrate success with statistical and problem-solving methodologies.
    • Excellent knowledge of the principles for Quality Engineering and Quality management as related to validation process on medical devices.
    • Proficient with Minitab or other statistical software, MS Word, Excel, and MS project.
    Preferred Requirements:
    • Strong understanding of failure analysis, test methods and engineering tolerances.
    • Strong verbal, written and interpersonal skills.
    • Six Sigma Certification Desired.
    • ASQ CQE
    • Working knowledge of 21CFR820, 21CFR210 & 21CFR211 ISO 13485.
    • Project Management experience.
    • Certified Quality Engineer and Certified Quality Auditor (preferred).

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